The Efficacy and Safety of Raphamin in the Treatment of Acute Rhinosinusitis in Adult Patients
Recruiting
Phase 3
Interventional Study
Rhinosinusitis
Rhinosinusitis Acute
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 552 (estimated)
- Sponsor
- Materia Medica Holding · Industry
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About This Trial
Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial of the efficacy and safety of Raphamin in the treatment of acute rhinosinusitis in adult patients.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Male and female aged 18 - 75 years.
2. Diagnosis of acute rhinosinusitis:
* 8-12 points on MSS scale;
* no more than 3 severe symptoms (3 points on the MSS scale)
* facial pain/heaviness in the facial area 1-2 points on the MSS scale.
3. Disease duration up to 48 ho…
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